BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940022 · Supplement: S001 · Decision Aug 2, 1996
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2
    PMA Number
    P940022
    Supplement Number
    S001
    Advisory Committee
    Ear, Nose, Throat
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 2, 1996
    Date Received
    April 5, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE DESIGN OF THE CLARION MULTI-STRATEGY COCHLEAR IMPALTN FROM THE ORIGINAL 1.0 VERSION TO THE MINIATURIZED 1.2 VERSION